DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The current office action is made responsive to claims filed 01/31/2025.
Claims 1-20 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Just (US 20130172715 A1).
Regarding claim 1, Just teaches a capless distal coupler ([0047] teaches the electrode support structure assembly as comprising first and second elements for receiving a plurality of splines) for coupling a basket to a shaft of a catheter ([0050] discusses the second end portion of the second element as being configured to mate with a tubing assembly), the capless distal coupler comprising:
a first wall (Fig. 4-; first element 130 having axial end 137) defining a central lumen;
a plurality of projections (Fig. 4-7; outer radial surface 132 of first element 130 is taught as being part of radially extending wall 135) extending outward from the first wall; and
a plurality of slots (Fig. 4-7; slots 134), wherein each slot is defined by the first wall, and two of the plurality of projections, wherein each slot is configured to receive a single spline of a basket ([0047]- [0048]).
Regarding claim 3, Just teaches the capless distal coupler of claim 1, wherein each slot is positioned opposite to another slot ([0039] teaches there being eight splines, which may be evenly spaced circumferentially).
Regarding claim 4, Just teaches the capless distal coupler of claim 1, wherein the first wall defines at least one through hole for securing the capless distal coupler to the shaft ([0050] discusses the second element as being positioned within the first element, specifically within the opening formed by the outer radial surface, as can be seen in Fig. 4-7, so as to mate the first element with the tubing assembly).
Regarding claim 5, Just teaches the capless distal coupler of claim 1, wherein each projection defines a retention slot configured to receive a spline retention feature of a basket spline (Fig. 7; outer radial surface 141 is shown as being disposed radially inward of the fist element to receive a portion of the spline which is proximal of the distalmost end of the spline, as can be seen by the position P2; [0048]- [0050]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Just (US 20130172715 A1) in view of Kordis (US 20120271140 A1).
Regarding claim 2, Just teaches the capless distal coupler of claim 1.
However, Just fails to teach the capless distal coupler, wherein each projection of the plurality of projections comprises a curved leading section with a greater radius of curvature than a curved trailing section.
Kordis teaches a device for insertion within the body of a patient having an elongate tubular member, a plurality of flexible splines, a plurality of electrodes, and a distal tip (Abstract, [0127]).
Kordis further teaches the distal tip as including spline alignment posts which are spaced apart so that splines may fit to be securely held, these posts are being shown as having a greater radius of curvature at a portion where the splines are inserted than at the center of the distal tip ([0128]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the distal tip as having spline alignment posts, as is taught by Kordis, into the distal portion of the electrode support assembly having a plurality of slots as is taught by Just, to produce the predictable result of securely holding splines within slots, as is taught by Kordis, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Just (US 20130172715 A1) in view of Schaer (US 5782760 A) and Zhou ‘759 (US 20210212759 A1).
Regarding claim 6, Just teaches the capless distal coupler of claim 1.
However, Just fails to teach the capless distal coupler being coupled to a shaft comprising: a tube forming an inner layer of the shaft; a braid positioned on, and coextensive with, the tube; a coil positioned on a first end section of the braid; and at least one material forming an outer layer of the shaft.
Schaer teaches a catheter having electrodes for insertion into a body of a patient containing a plurality of layers insulators and conductors so as to form the elongated tubular member of the shaft of the device (Abstract, Col. 3, lines 5-12).
Schaer further teaches a tube (Fig. 13; lining 54) forming an inner layer of the shaft; a braid (Fig. 13; braided tubular member 15) positioned on, and coextensive with, the tube; a coil (Fig. 13; coil 51) positioned on a first end section of the braid; and at least one material forming an outer layer of the shaft (Fig. 13; material forming shaft 11).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of a tube forming an inner layer, a braid and coil positioned on the tube, and a material forming an outer layer of a shaft for insertion into a patient, as is taught by Schaer, into the device having a shaft for insertion into a patient as is taught by Just, to produce the predictable result of using a known shaft structure for insertion into a patient within a device for insertion into a patient, as is taught by Schaer, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
However, Schaer fails to teach the tube as being a polymeric tube and the material which forms the outer layer of the shaft as being a polymer.
Zhou ‘759 teaches a medical device for insertion into a patient having a distal expanding member containing a plurality of curved electrode portions and a balloon portion which are connected at a distal and proximal end of the electrode and balloon portions and a shaft portion at the proximal end for insertion into the patient (Abstract, [0026], [0027]).
Zhou ‘759 further teaches shaft portion having an embedded conductor, such as plurality of braided wire rods ([0065]), which are interposed between an inner first tubular body and a second tubular body, both of which are insulative, in a manner in which the embedded portion is covered by the material without any gap so as to reliably suppress electrical short-circuits of the embedded portions ([0033]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the tube and outer layer as being polymers, as is taught by Zhou ‘759, into the inner layer and outer layer of the shaft which cover the metal members, such as the braid, as is taught by Schaer, to produce the predictable result of reliably suppressing electrical short circuits of embedded materials, as is taught by Zhou ‘759, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 7, in accordance with the above rejection of claim 6, Schaer further teaches the capless distal coupler of claim 6, the at least one polymer comprising:
a first material (Fig. 13; the material of the enlarged distal end 53) with a first hardness over the coil;
a second material (Fig. 13; the material of the solder 52) with a second hardness over an intermediate section of the braid; and
a third material (Fig. 13; the material of the shaft 11) with a third hardness over a second end section of the braid.
In accordance with the above rejection of claim 6, Zhou ’759 further teaches these materials as being polymers and therefore having durometer hardnesses ([0031], [0033]).
Further, it should be understood as broadly as is currently claimed that all polymers will have a durometer hardness as this is a characteristic of a polymer and therefore, in accordance with MPEP 2114 this currently taught structure of these materials being polymers, would this property of having durometer hardness of the claim limitation, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Just (US 20130172715 A1) in view of Govari ‘371 (US 20210196371 A1) and Zhou ‘128 (US 20220008128 A1).
Regarding claim 8, Just teaches the capless distal coupler of claim 1.
However, Just fails to teach the capless distal coupler further comprising at least one magnetic sensor.
Govari ’371 teaches an electrical apparatus having an ablation catheter including an electrode (Abstract, [0001]).
Govari ’371 further teaches the electrodes as being capable of measuring a position of said electrode based on magnetic measurements (Abstract, [0016], [0026]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated an electrode as having a magnetic sensor so as determine the position of said electrode, as is taught by Govari ’371, into the at least one electrode as is taught by Just, to produce the predictable result of determining the position of the electrode, as is taught by Govari ’371, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
However, this incorporation of Govari ’371 fails to teach the magnetic sensor as being positioned in a groove along an outer surface of the capless distal coupler.
Zhou ’128 teaches a medical device having a plurality of expandable electrodes which are connected at a distal portion (Abstract).
Zhou ’128 further teaches the medical device as including at least one electrode at a distal end surface of the shaft which couples the electrodes, so as to contact tissue at a distal end of the device ([0066]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the position of electrodes as being at the distalmost end of the device, as is taught by Zhou ’128, into the device having electrodes, such as the electrodes which are magnetic sensors, as is taught by incorporation of Govari ’371 into Just, to produce the predictable result of contacting tissue at a distal end of a device with an electrode, as is taught by Zhou ’128, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Just (US 20130172715 A1) in view of Zhou ‘759 (US 20210212759 A1).
Regarding claim 9, Just teaches the capless distal coupler of claim 1, wherein the plurality of projections and the plurality of slots are located in a basket securement region of the capless distal coupler ([0047]- [0050]).
However, Just fails to teach the capless distal coupler of claim 1, the capless distal coupler further comprising a balloon securement region proximal to the basket securement region.
Zhou’759 teaches a medical device for insertion into a patient having a distal expanding member containing a plurality of curved electrode portions and a balloon portion which are connected at a distal and proximal end of the electrode and balloon portions and a shaft portion at the proximal end for insertion into the patient (Abstract, [0026], [0027]).
Zhou ‘759 further teaches the balloon portion as being fixedly connected to an inner tube at a position proximal to the position at which the electrodes are connected to the inner tube and is provided so as to reliably spread the electrode portion ([0032], [0042]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the balloon and the distal connection of said balloon proximal to the distal connection of the plurality of expanding electrodes, as is taught by Zhou ‘759, into the electrode support structure having a plurality of expanding splines which are connected to an inner tubing assembly as is taught by Just, to produce the predictable result of reliably spreading the electrode portion, as is taught by Zhou ‘759, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Just (US 20130172715 A1) in view of Zhou ‘759 (US 20210212759 A1) further in view of Hooven (US 20130253622 A1).
Regarding claim 10, Zhou ’759 teaches the capless distal coupler of claim 9, wherein the balloon securement region comprises a covered section for securing a balloon to the capless distal coupler ([0039]).
However, Zhou ’759 fails to teach the covered section as being overmolded.
Hooven teaches an apparatus, such as a catheter having at least one balloon and at least one electrode having wires which connect said electrode to other elements of the catheter ([0070]- [0071], [0119]).
Hooven further teaches attaching a plurality of elements, such as the balloon to the shaft of the catheter or to form the electrodes for the catheter, by any of a variety of known suitable manners, such as overmolding ([0071], [0119]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of attaching or forming elements of a catheter, such as electrodes or balloon by using overmolding, as is taught by Hooven, into the apparatus having elements, such as at least one balloon and electrodes as is taught by Zhou ’759, to produce the predictable result of using a known suitable manner of attaching or forming portions of a catheter to attach or form portions of a catheter, as is taught by Hooven, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou ‘759 (US 20210212759 A1) in view of Govari ‘371 (US 20210196371 A1), Zhou ‘128 (US 20220008128 A1), and Govari ‘370 (US 20220193370 A1).
Regarding claim 11, Zhou ‘759 teaches a medical device (Fig. 1; medical device 10) comprising:
a distal coupler (Fig. 1; distal portion of medical device 10) comprising:
a basket securement region (Fig. 9; fixing portion 29);
a balloon securement region proximal to the basket securement region ([0029] teaches the fixing portion for fixing a distal portion of the electrode portion as being fixed to an outer peripheral surface on a distal side from a position where the balloon is fixed); and
a proximal coupler (Fig. 5; distal portion of shaft 20) comprising:
a balloon securement region (Fig. 3; the proximal portion of the balloon 30 is taught as being fixed to an outer peripheral surface of the step portion 26); and
a basket securement region (Fig. 5; connection section 54) proximal to the balloon securement region (Fig. 5; connection section 54 is taught as being disposed on the outer peripheral surface of the step portion 26); and
a basket (Fig. 5; plurality of electrode portions 40) coupled to the basket securement regions of the distal and proximal couplers; and
a balloon (Fig. 5; balloon 30) positioned in the basket, the balloon coupled to the balloon securement regions of the distal and proximal couplers.
However, Zhou ‘759 fails to teach the medical device comprising: at least one magnetic sensor positioned along an outer surface of the distal coupler in a groove.
However, Just fails to teach the capless distal coupler further comprising at least one magnetic sensor.
Govari ’371 teaches an electrical apparatus having an ablation catheter including an electrode (Abstract, [0001]).
Govari ’371 further teaches the electrodes as being capable of measuring a position of said electrode based on magnetic measurements (Abstract, [0016], [0026]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated an electrode as having a magnetic sensor so as determine the position of said electrode, as is taught by Govari ’371, into the at least one electrode as is taught by Zhou ‘759, to produce the predictable result of determining the position of the electrode, as is taught by Govari ’371, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
However, this incorporation of Govari ’371 fails to teach the magnetic sensor as being positioned in a groove along an outer surface of the capless distal coupler.
Zhou ’128 teaches a medical device having a plurality of expandable electrodes which are connected at a distal portion (Abstract).
Zhou ’128 further teaches the medical device as including at least one electrode at a distal end surface of the shaft which couples the electrodes, so as to contact tissue at a distal end of the device ([0066]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the position of electrodes as being at the distalmost end of the device, as is taught by Zhou ’128, into the device having electrodes, such as the electrodes which are magnetic sensors, as is taught by incorporation of Govari ’371 into Zhou ‘759, to produce the predictable result of contacting tissue at a distal end of a device with an electrode, as is taught by Zhou ’128, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Zhou ‘759 further fails to teach the medical device comprising: at least one magnetic sensor secured to an outer surface of the proximal coupler.
Zhou ’759 as modified further teaches an expandable element having a plurality of electrodes ([0029]) and a distal magnetic sensor (taught by the incorporation of Govari ’371, [0016]).
Govari ’370 teaches a catheter including a system having an expandable distal end assembly, such as a basket or balloon distal end assembly, of a catheter having at least one sensor to determine the position of said at least one magnetic sensor within a given coordinate space ([0035]).
Govari ’370 further teaches the at least one magnetic sensor as being a magnetic sensor distal of the distal-end assembly and proximal of the distal end assembly (Fig. 2B; magnetic sensors 50A and 50B).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of a magnetic sensor proximal of the distal end assembly in addition to the magnetic sensor being at a distal position of the distal end assembly, as is taught by Govari ’370, into the expandable assembly having a magnetic sensor at a distal position of the assembly as is taught by Zhou ‘759 as currently modified, to produce the predictable result of determining the portion of the distal end assembly, as is taught by Govari ’370, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 12, Zhou ‘759 teaches the medical device of claim 11, the basket further comprising one or more electrodes for ablation and/or mapping ([0052]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou ‘759 (US 20210212759 A1) in view of Govari ‘371 (US 20210196371 A1), Zhou ‘128 (US 20220008128 A1), and Govari ‘370 (US 20220193370 A1) further in view of Hooven (US 20130253622 A1).
Regarding claim 13, Zhou ’759 teaches the medical device of claim 11, the basket comprising a plurality of splines, each spline comprising at least one covered section and at least one section without covering, wherein each of the at least one section without covering is an electrode ([0039]).
However, Zhou ’759 fails to teach the covered section as being overmolded.
Hooven teaches an apparatus, such as a catheter having at least one balloon and at least one electrode having wires which connect said electrode to other elements of the catheter ([0070]- [0071], [0119]).
Hooven further teaches attaching a plurality of elements, such as the balloon to the shaft of the catheter or to form the electrodes for the catheter, by any of a variety of known suitable manners, such as overmolding ([0071], [0119]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of attaching or forming elements of a catheter, such as electrodes or balloon by using overmolding, as is taught by Hooven, into the apparatus having elements, such as at least one balloon and electrodes as is taught by Zhou ’759, to produce the predictable result of using a known suitable manner of attaching or forming portions of a catheter to attach or form portions of a catheter, as is taught by Hooven, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 14, Zhou ‘759 as modified teaches the medical device of claim 11, wherein the balloon securement region of the distal coupler comprises polymer portion formed of a material with a durometer hardness similar to a durometer hardness of the balloon for bonding the balloon to the distal coupler (Zhou ‘759 as currently modified teaches this limitation as broadly as is currently claimed as the term “similar” is a term of degree, see MPEP 2173.05(b)(i) for more information of terms of degrees, and therefore any portions formed of materials having the required structure of having a durometer hardness in view of the current modification teach this limitation as broadly as is currently claimed, further it should be noted that Zhou ‘759 teaches the balloon portion as being formed of the same material as the elements to which it is attached [0030], [0033]).
In accordance with the above rejection of claim 13, Hooven teaches the polymer portion as being an overmolded portion ([0071], [0119]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou ‘759 (US 20210212759 A1) in view of Govari ‘371 (US 20210196371 A1), Zhou ‘128 (US 20220008128 A1), and Govari ‘370 (US 20220193370 A1) further in view of Schaer (US 5782760 A).
Regarding claim 15, Zhou ‘759 teaches the medical device of claim 11.
However, Zhou ‘759 fails to teach the medical device further comprising a first shaft coupled to the distal coupler, the shaft comprising: a tube forming an inner layer of the shaft; a braid positioned on, and coextensive with, the tube; a coil positioned on a first end section of the braid.
Schaer teaches a catheter having electrodes for insertion into a body of a patient containing a plurality of layers insulators and conductors so as to form the elongated tubular member of the shaft of the device (Abstract, Col. 3, lines 5-12).
Schaer further teaches a tube (Fig. 13; lining 54) forming an inner layer of the shaft; a braid (Fig. 13; braided tubular member 15) positioned on, and coextensive with, the tube; a coil (Fig. 13; coil 51) positioned on a first end section of the braid; and at least one material forming an outer layer of the shaft (Fig. 13; material forming shaft 11).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of a tube forming an inner layer, a braid and coil positioned on the tube, and a material forming an outer layer of a shaft for insertion into a patient, as is taught by Schaer, into the device having a shaft for insertion into a patient as is taught by Zhou ‘759, to produce the predictable result of using a known shaft structure for insertion into a patient within a device for insertion into a patient, as is taught by Schaer, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
However, this incorporation of Schaer fails to teach the tube as being a polymeric tube and the material which forms the outer layer of the shaft as being a polymer.
Zhou ‘759 teaches a medical device for insertion into a patient having a distal expanding member containing a plurality of curved electrode portions and a balloon portion which are connected at a distal and proximal end of the electrode and balloon portions and a shaft portion at the proximal end for insertion into the patient (Abstract, [0026], [0027]).
Zhou ‘759 further teaches shaft portion having an embedded conductor, such as plurality of braided wire rods ([0065]), which are interposed between an inner first tubular body and a second tubular body, both of which are insulative, in a manner in which the embedded portion is covered by the material without any gap so as to reliably suppress electrical short-circuits of the embedded portions ([0033]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the tube and outer layer as being polymers, as is taught by Zhou ‘759, into the inner layer and outer layer of the shaft which cover the metal members, such as the braid, as is taught by Schaer, to produce the predictable result of reliably suppressing electrical short circuits of embedded materials, as is taught by Zhou ‘759, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer (US 5782760 A) in view of Zhou ‘759 (US 20210212759 A1).
Regarding claim 16, Schaer teaches a shaft for a medical device (Col. 6, Likes 65-67) comprising:
a tube (Fig. 15; inner tubular member 60) forming an inner layer of the shaft;
a braid (Fig. 15; braided tubular member 15) positioned on, and coextensive with, the tube;
a coil (Fig. 15; coil 63) positioned on a first end section of the braid; and
at least one material forming an outer layer of the shaft (Fig. 15; material forming shaft 11).
However, Schaer fails to teach the tube as being a polymeric tube and the material which forms the outer layer of the shaft as being a polymer.
Zhou ‘759 teaches a medical device for insertion into a patient having a distal expanding member containing a plurality of curved electrode portions and a balloon portion which are connected at a distal and proximal end of the electrode and balloon portions and a shaft portion at the proximal end for insertion into the patient (Abstract, [0026], [0027]).
Zhou ‘759 further teaches shaft portion having an embedded conductor, such as plurality of braided wire rods ([0065]), which are interposed between an inner first tubular body and a second tubular body, both of which are insulative, in a manner in which the embedded portion is covered by the material without any gap so as to reliably suppress electrical short-circuits of the embedded portions ([0033]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the tube and outer layer as being polymers, as is taught by Zhou ‘759, into the inner layer and outer layer of the shaft which cover the metal members, such as the braid, as is taught by Schaer, to produce the predictable result of reliably suppressing electrical short circuits of embedded materials, as is taught by Zhou ‘759, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 17, Zhou ‘759 teaches the shaft of claim 16, wherein the polymeric tube comprises polytetrafluoroethylene (PTFE) ([0031]), the at least one polymer comprises polyether block amide (PEBA) ([0031]).
Regarding claim 18, Schaer teaches the shaft of claim 17, wherein the at least one polymer comprises:
a first polymer (Fig. 15; solder 64) with a first hardness over the coil;
a second polymer with a second hardness over an intermediate section (Fig. 15; inner tubular member 60) of the braid; and
a third polymer with a third hardness over a second end section of the braid (Fig. 15; shaft 11).
In accordance with the above rejection of claim 16, Zhou ‘759 further teaches these materials as being polymers and therefore having durometer hardnesses ([0031], [0033]).
Further, it should be understood as broadly as is currently claimed that all polymers will have a durometer hardness as this is a characteristic of a polymer and therefore, in accordance with MPEP 2114 this currently taught structure of these materials being polymers, would this property of having durometer hardness of the claim limitation, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics.
Regarding claim 19, Schaer teaches the shaft of claim 18, wherein a length of the second end section is greater than a length of the first end section and less than a length of the intermediate section (Fig. 15; inner tubular member 60 is shown as being longer than shaft 11 which is shown as being longer than solder 64).
Regarding claim 20, Schaer teaches the shaft of claim 16.
However, Schaer fails to teach the shaft, wherein the shaft is coupled to a distal coupler comprising a basket securement region.
Schaer further teaches that it is frequently difficult to maintain contain between the device and the target tissue and so to overcome this, it is desirable to provide an expandable positioning member, such as an inflatable balloon to ensure contact between the device and the desired tissue (Col. 6, Lines 38-55).
Zhou ‘759 teaches a medical device for insertion into a patient having a distal expanding member containing a plurality of curved electrode portions and a balloon portion which are connected at a distal and proximal end of the electrode and balloon portions and a shaft portion at the proximal end for insertion into the patient (Abstract, [0026], [0027]).
Zhou ‘759 further teaches the balloon portion as being fixedly connected to an inner tube at a position proximal to the position at which the electrodes are connected to the inner tube and is provided so as to reliably spread the electrode portion ([0032], [0042]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the curved electrode portion which surrounds the balloon to be spread to make contact, as is taught by Zhou ‘759, into the electrode support structure having a balloon to make contact with patient tissue, as is taught by Schaer, to produce the predictable result of reliably spreading the electrode portion, as is taught by Zhou ‘759, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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